UMIN-CTR Clinical Trial

Public title

A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial

Acronym

A study for the effects of ingestion of food constituents derived from microorganism on visual function.

Scientific Title

A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial

Scientific Title:Acronym

A study for the effects of ingestion of food constituents derived from microorganism on visual function.

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of ingestion of food constituents derived from microorganism on improving visual function.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Contrast sensitivity, Critical flicker frequency, visual analogue scale.
Evaluate at points of 4-week and 8-week.

Key secondary outcomes

refract, best-corrected visual acuity, ear point distance (amplitude of accommodation), schirmer's test, DEQS

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Food Constituent derived from microorganism, once a day for 8 weeks

Interventions/Control_2

Placebo not containing food Constituent derived from microorganism, once a day for 8 weeks

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

35

years-old

<=

Age-upper limit

45

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Men and women aged from 35 to 45.
(2)Subjects with subjective eye fatigue.
(3)Individuals who do the VDT works more than 6 hours a day for more than 1 year.
(4)Individuals giving written informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
(5)Subjects who are judged suitable for this study by the investigator.

Key exclusion criteria

1 Subjects who have amblyopia or strabismus
2 Subjects who are judged as presbyopia (the control width is less than 2.5D for dominant eye)
3 Subjects who have an uncorrected serious refractive error for dominant eye
4 Subjects who have undergone ophthalmic surgery for dominant eye
5 Best-corrected visual acuity<1.0 for dominant eye
6 Subjects who have a serious eye disease or history of eye disease
7 Subjects who are under treatment of some chronic disease and use medicines or medical supplies continuously
8 Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease) thyroid gland disease, adrenal gland disease, digestive system disease and/or metabolic disorder
9 Subjects who can't stop food similar to test foods or take drugs, health foods
10 Subjects with excessive alcohol-drinking behaviors
11 Subjects who regularly take drugs or health foods which may have effects to the eyes or expected to use during study
12 Subjects who can't stop take drugs or health foods which may have effects to immune functions
13 Subjects having allergy to food or medicine
14 Subjects who can't stop drinking for 2 days until the pre-check day and check days
15 Subjects who have a history of pollinosis
16 Subjects who have tendency to get diarrhea by eating dairy product
17 Subjects who have under treatment or a history of drug addiction and/or alcoholism
18 Subjects who and whose family work in a company developing or manufacturing functional foods
19 Subjects who can't execute a display work load test
20 Subjects who are participating or willing to participate in other clinical trials or in the last 3 months
21 Subjects who are or plan to be pregnant, breastfeeding during study
22 Subjects who are judged as unsuitable by doctor for anthropometric measurements or physical examination value
23 Subjects who are judged as unsuitable for lifestyle questionnaire
24 Subjects who are judged as unsuitable by doctor

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Masamaru Inaba

Organization

Inaba Eye Clinic

Division name

Director

Zip code

Address

1F Osakaekimaedaiichi building, 1-3-1 ,Umeda, Kita-ku, Osaka, Japan

TEL

06-6343-2174

Email

inaba@ganka.com

Name of contact person

1st name
Middle name
Last name	Chiharu Goto

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

c.goto@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

Kirin Company, Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

05

Month

13

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

06

Month

02

Day

Last modified on

2018

Year

06

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026036